# K140441: BI-Flex Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Promepla Sam
- Decided: Jun 17, 2014 after 116 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961904 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120160: Rocamed Rocaus Platinum, Promepla Sam (2012) Summary page 1.

## Most influential descendants
- K182144: Bi-Flex Evo (2018), 0 descendants of its own

## Indications for use
The Bi-Flex Ureteral Access Sheath is intended to be a conduit for passage of endloscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

Source page: https://510kreport.com/device/K140441
Methodology: https://510kreport.com/methodology